Skin ulcers are a significant clinical problem and can cause even more serious complications such as, for example, gangrene, systemic inflammatory syndrome, and sepsis. When these complications occur in skin ulcers on the extremities current treatment regimens may require amputations including above-the-knee leg amputation (AKA), below-the-knee leg amputations (BKA), and digital amputations with their obvious implications for the patient.
Skin ulcers have many causes, including venous insufficiency, arterial insufficiency, ischemic pressure, and neuropathies. Venous skin ulcers are the most common type of leg skin ulcers with women affected more than men. Venous skin ulcers are associated with venous hypertension and varicosities. Arterial skin ulcers are typically found in elderly patients with history of cardiac or cerebrovascular disease, leg claudication, impotence, and pain in distal foot. Pressure skin ulcers result from tissue ischemia. Pressure skin ulcers are commonly deep and often located over bony prominences. Neuropathic skin ulcers are associated with trauma, prolonged pressure, usually plantar aspect of feet in patients with, for example, diabetes, neurologic disorders or Leprosy.
Diabetes is also a frequent cause of foot skin ulcers. Diabetes is highly prevalent in the U.S. In addition, type-2 diabetes appears to be increasing in the U.S. Diabetes is the leading nontraumatic cause of amputation in the U.S. The total number of lower-extremity amputations (LEAs) in diabetic patients in the U.S. is over 80,000 annually. The 3-year mortality rate after a diabetic LEA is between 35 and 50%. Direct medical costs for diabetic LEAs in the U.S. are exceptionally high. Foot skin ulcers precede about 85% of LEAs in patients with diabetes. The 1-year incidence of new foot skin ulcers in patients with diabetes in the U.S. ranges from 1.0 to 2.6%. V. R. Driver et al., Diabetes Care 2005 28:248-253.
Work-related burns are a leading cause of acute occupational injury in the U.S. An estimated 20-30% of all hospitalizations due to burn injuries result from workplace exposures. These injuries cause substantial direct costs and resulted in significant loss of productivity.
Peritonitis is an inflammation of the internal lining of the abdominal cavity. The most common causes of peritonitis are bacterial infection and chemical irritation. Bacterial peritonitis is usually secondary to bacterial penetration through an abdominal organ as occurs with disorders such as appendicitis, acute cholecystitis, peptic ulcers, diverticulitis, bowel obstruction, pancreatitis, mesenteric thrombosis, pelvic inflammatory disease, tumor or penetrating trauma, or combinations thereof. In addition, spontaneous bacterial peritonitis (SBP) can develop without an obvious source of contamination. SBP is frequently associated with immunosuppressed states, such as cirrhotic ascites or the nephrotic syndrome. Peritonitis is also a common complication of chronic ambulatory peritoneal dialysis (CAPD).
Periodontal (gum) diseases, including gingivitis and periodontitis, are serious infections that if left untreated, can lead to tooth loss. Periodontal disease can affect one tooth or many teeth. Periodontal disease begins when the bacteria in “plaque,” a sticky, colorless film that constantly forms on teeth, causes the gums to become inflamed. In the mildest form of the disease, gingivitis, the gums redden, swell and bleed easily. Gingivitis is often caused by inadequate oral hygiene. Gingivitis is reversible with professional treatment and good oral home care.
However, untreated gingivitis can advance to periodontitis. With time, plaque can spread and grow below the gum line. Toxins produced by the bacteria in plaque irritate the gums. Gums can then separate from the teeth, forming spaces between the teeth and gums that become infected. As the disease progresses, gum tissue and bone are destroyed. Eventually, teeth can become loose and may have to be removed by periodontal surgery.
In addition, root canal infection, an infectious disease of bacterial etiology, is an important cause of tooth loss in the world. Current therapeutic modalities include scaling and root plaining of the surfaces of the teeth to eliminate bacterial plaque and calculus, and the use of antiseptic solutions to combat the infectious process caused by a wide spectrum of oral micro-organisms. These antiseptics, however, have high toxicity and consequently cannot be used for prolonged periods. Unfortunately, some of the commonly used antiseptics have adverse side effects such as distortion of taste and staining of teeth.
Non-toxic disinfectants are used to eradicate microorganisms, including bacteria, viruses and spores, in variety of settings. For example, such disinfectants find application in wound care, medical device sterilization, food sterilization, hospitals, consumer households and anti-bioterrorism.
Oxidative-reductive potential (“ORP”) water solutions provide highly effective, yet non-toxic treatments for the foregoing condition, as well as other medical conditions. Further, ORP water solutions are effective disinfectants. Known ORP water solutions, however, require rather costly electrolytic manufacturing processes to produce, and also have stability and shelf life problems. There is a need for an ORP water product, which is non-toxic and effective for treating wounds and other medical conditions (e.g., infections), and yet relatively inexpensive to manufacture and has improved shelf life. The present invention provides such an ORP water product, and methods of making and using such a product.